Kornimate/medical-research-clean huggingface dataset:
assess the safety and efficacy of individually tailored prophylaxis with human-cl rhfviii in patients with severe haemophilia a

Conditions: Severe Haemophilia A

Summary: to compare the number of breakthrough bleeds under tailored prophylaxis with human cell line recombinant factor fviii (human-cl rhfviii) with the historical bleeding rate from patients who received human-cl rhfviii as on demand treatment.

there were 3 phases in this study: (1) an initial pharmacokinetic (pk) assessment in which participants received a single infusion of 60±5 iu/kg of human-cl rhfviii; blood samples were collected for 72 hours following the infusion. (2) prophylactic treatment-phase i during which participants received infusions of 30-40 iu/kg of human-cl rhfviii every other day or 3x/week for 1-3 months. (3) prophylactic treatment-phase ii during which the dose and dosing interval were determined individually from data gathered in the initial pk assessment. the maximum dosing interval with a dose of ≤ 60-80 iu/kg that maintains a trough level of ≥ 0.01 iu/ml was determined. participants were treated for 6 months.

Eligibility criteria:
inclusion criteria: * severe haemophilia a (fviii:c \< 1%) according to medical history. * male patients ≥ 18 years old. * previous treatment with a fviii concentrate (regular prophylaxis with good compliance or on-demand treatment) for at least 150 exposure days (eds). * good documentation regarding dosing and bleeding frequency in the 6 months preceding study start. * immunocompetence (cd4+ count \> 200/microliter). * hiv-negative, if positive, viral load \< 200 particles/microliter or \< 400,000 copies/ml. * freely given written informed consent exclusion criteria: * any coagulation disorder other than haemophilia a. * present or past fviii inhibitor activity (\> 0.6 bethesda unit \[bu\]) * severe liver or kidney disease.
prospective evaluation of ivosidenib maintenance following allogeneic stem cell transplantation in patients with acute myeloid leukemia or high-risk myelodysplastic neoplasia with idh1 (isocitrate dehydrogenase 1) mutation

Conditions: AML; MDS

Summary: maintenance of aml or mds patients with known idh1 mutation after allogeneic stem cell transplantation within past 100 days

determination of the efficacy of ivosidenib to improve event-free survival when given as maintenance therapy following allosct.

Eligibility criteria:
inclusion criterion: * aml or mds with idh1 mutation exclusion criteria: * active gvhd (graft vs host disease) grade iii-iv according to harris criteria requiring steroids \>1mg/ kg prednisolone equivalent
three drugs in advanced gastric cancer neoadjuvant chemotherapy for stage ⅲ clinical study

Conditions: Gastric Cancer

Summary: the purpose of this study is to assess the relationship of pcr rate and efficacy by comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer patients.

eligible patients will be randomly assigned by a randomisation system in a 1:1:1 ratio to three group. the group a wil receive four cycles of dox (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.the group b wil receive four cycles of xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of xelox as adjuvant therapy.the group c wil receive eight cycles of xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically proven in operable advanced gastric adenocarcinoma; 2. subjects who were identified as potentially resectable cases by a multidisciplinary consultation; 3. kps\> 80; ecog score: 0-1; 4. expected survival\> 6 months; 5. age 20 -60; 6. major organ function has to meet the following criteria: neutrophil count ≥1.5 × 109 / l, platelet count ≥100 × 109 / l, hemoglobin ≥90g / l, liver function \<1.5 times the upper limit of normal, serum bilirubin ≤1.0 × unl, serum creatinine \<1.5 × unl, pt-inr / ptt \<1.7 times the upper limit of normal; 7. subjects has to voluntarily join the study and sign the informed consent form for the study; exclusion criteria: 1. associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs; 2. history of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product; 3. receiving any form of chemotherapy or other study medication; 4. pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method; 5. associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding.

Keywords: resectable advanced gastric cancer
citalopram vs clomipramine vs placebo in recurrent depression

Conditions: Depression

Summary: citalopram and clomipramine are better than placebo in preventing new episodes of depression in patients with recurrent depression


Eligibility criteria:
inclusion criteria: * patients with recurrent depression * sustained response achieved (3 consecutive monthly ratings at the hds below 13)after a treatment requiring index episode exclusion criteria: * contraindications to study medications * pregnancy * substance abuse
medtronic evolut™ expand tavr i feasibility study

Conditions: Aortic Valve Stenosis

Summary: the purpose of the study is to obtain safety and effectiveness data of the medtronic evolut™ pro+ tavr system for the treatment of severe, asymptomatic aortic stenosis.

single-arm, descriptive, multi-center, international all subjects will be treated with a medtronic evolut™ pro+ tavr system. subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.

Eligibility criteria:
key inclusion criteria: * severe aortic stenosis, defined as: aortic valve area ≤ 1.0 cm\^2, or aortic valve area index ≤ 0.6 cm\^2/m\^2, and mean gradient ≥ 40 mmhg or vmax ≥ 4.0 m/sec * subject denies symptoms attributable to aortic stenosis, including but not limited to: * dyspnea on rest or exertion * angina * syncope in the absence of another identifiable cause * fatigue * left ventricular ejection fraction (lvef) \>50% key exclusion criteria: * age \<65 years * class i indication for cardiac surgery * bicuspid, unicuspid, or quadricuspid aortic valve * in need of and suitable for coronary revascularization
gluteus medius latent trigger point and muscle strength in healthy subjects

Conditions: Myofascial Pain Syndrome; Muscle Weakness

Summary: this study aimed to investigate the relationship between latent mtrps and gluteus medius muscle strength in a group of healthy adults.

latent myofascial trigger points (mtrps) do not cause spontaneous pain; however, they may lead to a limited range of motion and muscle weakness. we hypothesized that latent mtrps might decrease gluteus medius muscle strength in healthy individuals. forty-eight healthy men will be included in the study. trigger point examination for the gluteus medius will be performed bilaterally. subjects with one or more trigger points on the dominant side and those without any trigger points will be assigned to two groups. muscle strength for gluteus medius will be assessed with a manual muscle tester using the "break test" technique on both sides. the subjects and the examiners will be blinded. for statistical analysis, the independent sample t-test was used to compare the intergroup differences.

Eligibility criteria:
inclusion criteria: * patient age: 18-40 years. * absence of musculoskeletal complaints related to the lumbar, sacroiliac, and hip area. * absence of bilateral latent mtrp in the gluteus medius muscle. * latent trigger point in the gluteus medius muscle on the dominant side with palpation. exclusion criteria: * a history of medical treatment, physical therapy, injection therapy, or surgical treatment related to the lumbar, sacroiliac, and hip area. * history of trauma, or malignancy or being pregnant, or if the patient is in the lactation period. * bilateral latent mtrp in the gluteus medius muscle. * presence of latent mtrp on the non-dominant side.

Keywords: trigger point gluteus medius muscle
changes of pad weight results and urethral pressure profiles after reduction of cystocele by vaginal gauze packing

Conditions: Cystocele

Summary: the purpose of this study is to retrospectively review the impact of vaginal packing on the urodynamic studies, especially for urethral pressure profiles.


Eligibility criteria:
inclusion criteria: * patients with \>= stage ii cystocele and underwent urodynamic studies exclusion criteria: * patients less than 20 patients
dye assisted lymphatic sparing subinguinal varicocelectomy

Conditions: Varicocele

Summary: we prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation with 40 controls in whom no mapping technique was adopted in the period between january 2008 and feb. 2010, in mansoura university hospital ward 7.after surgery, the patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications with mean follow up was 15+ 7months.

methods. we prospectively compared outcomes of subinguinal varicocelectomy for 40 patients who received 2 ml intratunical space injection of methylene blue before spermatic vein ligation with 40 controls in whom no mapping technique was adopted in the period between january 2008 and feb. 2010, in mansoura university hospital ward 7.after surgery, the patients were assessed at 2 weeks,6 and 12 months for varicocele recurrence, hydrocele formation, atrophy, pain or other complications with mean follow up was 15+ 7months. results: there were no intraoperative complications in either group. there were no adverse reactions, scrotal haematomas or atrophy. in group 1, no patient had a hydrocele at 3 months after surgery. by contrast, in group 2 (surgery alone) there were four cases of secondary hydrocele (10%; p=0.025)); no testicular hypertrophy was observed following lymphatic sparing surgery , one patient in each group had varicocele recurrence. pregnancy was reported in 30 patients (37.5%) during a follow up period, 17 of them (42.5%) were group(1),p \>0.34. difference was not significantly different among the two groups

Eligibility criteria:
inclusion criteria: * all left sided varicocele with impaired sperm counts, testicular pain and/or testicular atrophy exclusion criteria: * were preexisting hydrocele, previous groin surgery, concomitant hernia, allergy against methylene blue

Keywords: varicocele, methylene blue, varicocelectomy, hydrocele,
the prevention options for women evaluation research (power) cohort

Conditions: HIV/AIDS

Summary: the power cohort study is a prep implementation project to demonstrate pre-exposure prophylaxis (prep) delivery for young women in cape town and johannesburg, south africa and kisumu, kenya.

prep will be delivered to young women according to emerging national guidelines in family planning clinics (kisumu, kenya), youth friendly clinics (johannesburg, south africa), and mobile youth friendly clinics (cape town, south africa). the investigators will evaluate prep delivery and follow cohorts of young women at each clinic location to understand prep uptake and use. in the kisumu clinics, the investigators will also offer expedited partner therapy and partner hiv self-tests to women who test positive for chlamydia and/or gonorrhea. at one clinic in johannesburg, the investigators will evaluate the use of a decision support tool to improve the decision to initiate prep.

Eligibility criteria:
inclusion criteria: * age 16-25 (16 and 17 year olds, where permissible by national regulations and local irb approval) * able and willing to provide written informed consent * recently sexually active (defined as having had vaginal intercourse at least once in the previous three months) * hiv uninfected based on negative hiv rapid tests, on the date of enrollment

Keywords: pre-exposure prophylaxis young women delivery of health care hiv infections/prevention
botox in the healing of surgical wounds of the neck

Conditions: Scar

Summary: the investigators hypothesize that botox a will reduce scarring and improve healing of surgical neck wounds.

botulinum toxin a is a toxin produced by the anaerobic bacterial species clostridium botulinum. the toxin specifically inhibits release of the neurotransmitter acetylcholine at synaptic junctions, thus preventing neuromuscular transmission, and inducing paralysis of the muscle. previous studies have indicated that tensile forces on the skin may affect the healing of a wound. these forces act against the immature collagen laid down during wound healing and may stimulate overgrowth, thereby contributing to the formation of hypertrophic scars or keloids. using botox to paralyse the underlying muscles may reduce the tensile force on the overlying skin, and thus reduce scar formation and promote healing. botox has also been shown to affect the cell cycle distribution of fibroblasts derived from hypertrophic scars. the objective of this study is to determine the effects of btx-a in wound healing and the reduction of scar formation. patients undergoing a thyroidectomy or parathyroidectomy will be randomized to receive either btx-a injections along the surgical site or placebo immediately following closure. all incisions will be sutured in a similar fashion. btx-a or normal saline will then be injected along the platysma muscle. the patient and the surgeon will be blinded to the treatment arm. photographs will be taken of the surgical site at 4 weeks and 6 months. the patient and two otolaryngologists will independently score the healing of the wound using a standardized scoring method. the scores be compared between the two surgeons to determine correspondence and interobserver reliability. the scores of the two treatment arms will be compared to reveal the effect of btx-a on wound healing.

Eligibility criteria:
inclusion criteria: * all patients referred to the ent clinic for a thyroidectomy or parathyroidectomy exclusion criteria: * patients with missing information, including demographic information * patients lost to follow up or have been followed for less than 6 months * patients with known allergy to lidocaine * patients in whom botox would be contraindicated in: * known history of neuromuscular disorders (myasthenia gravis, amyotrophic lateral sclerosis, eaton-lambert syndrome) * pregnant women * known allergy to botox, albumin

Keywords: scar botox
safety and efficacy study of teduglutide in subjects with short bowel syndrome

Conditions: Short Bowel Syndrome

Summary: the purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (pk) of teduglutide compared with placebo in subjects with parenteral nutrition (pn)-dependent short bowel syndrome (sbs).

teduglutide is an analog of glucagon-like peptide 2 (glp-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines. the multicenter, double-blind, international phase iii trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. dosing will continue for a period of six months. the primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with sbs.

Eligibility criteria:
inclusion criteria: * men and women, aged 18 years of age or older at the time of signing the informed consent form (icf) * sbs as a result of major intestinal resection resulting in at least 12 months intravenous feeding * body weight must be less than 90 kg * at baseline, subjects must require pn treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable pn regimen for 4 weeks before dosing * body mass index (bmi) 18 to 27 kg/m2 * adequate hepatic and renal function exclusion criteria: * history of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state * history of alcohol or drug abuse (within previous year) * participation in a clinical study within 30 days prior to signing the icf, or concurrent participation in any clinical study * clinically significant laboratory abnormalities at the time of randomization * previous use of teduglutide (alx-0600) * prior use of native glp-2 within 3 months of screening visit * hospital admission within 1 month prior to screening visit * pregnant or lactating women * any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results. * presence of excluded disease: radiation enteritis, scleroderma, celiac disease, refractory/tropical sprue, pseudo-obstruction, active inflammatory bowel disease (ibd), pre-malignant/malignant change in colonoscopy biopsy or polypectomy, surgery scheduled within the time frame of the study, human immunodeficiency virus (hiv) positive test, immunological disorders, possible allergies to teduglutide or its constituents, significant, active, uncontrolled, untreated systemic diseases

Keywords: short bowel syndrome parenteral nutrition sbs
comparison of teriparatide with alendronate for treating glucocorticoid-induced osteoporosis

Conditions: Osteoporosis

Summary: osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. when taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." this study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.


Eligibility criteria:
inclusion criteria: * men or women age 21 years or older * taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening exclusion criteria: * taking bisphosphonates within past 6 months * more than 30 micrograms/day of estradiol or equivalent in past 3 months * history of alcoholism or drug abuse in past year * pregnant women or nursing mothers
percutaneous coronary angioplasty compared with exercise training in symptomatic coronary artery disease

Conditions: CAD; Stable Angina Pectoris

Summary: the purpose of this study is to compare coronary angioplasty with stent implantation with an exercise rehabilitation program in patients with stable coronary artery disease (cad).


Eligibility criteria:
inclusion criteria: * angiographically documented cad, with at least one coronary artery stenosis of more than 50% in a native segment never subjected to intervention, which is recommended for treatment with percutaneous transluminal coronary angioplasty (ptca). * stable coronary artery disease * eligible patients could be asymptomatic or have class i to iii angina (canadian cardiovascular society \[ccs\]) with documented myocardial ischemia * angina pectoris threshold \> 50 watt (cycle ergometry) * permanent residence should be within 25 km of training facility. exclusion criteria: * \ 70 years of age * patient currently participating in an exercise training program * unstable angina pectoris or myocardial infarction during the last 2 weeks * symptoms of ccs class iv * exercise limitations due to clinical conditions not related to cad * left ventricular ejection fraction (lvef) of \< 40% * ventricular arrhythmia (lown ivb) * hemodynamically significant valvular heart disease * previous cardiac surgery * ptca performed during the last 12 months * any major non-cardiac condition that would adversely affect survival during the duration of the study * reduced compliance
pelvic floor disorders among sexual minoritized women

Conditions: Sexual Function Disturbances; Pelvic Organ Prolapse; Urinary Incontinence; Fecal Incontinence

Summary: the investigators aim to perform cognitive interviews to assess how pelvic floor disorders impact sexual functioning in women who have sex with women (wsw). as a secondary objective there will be cognitive interviews to assess perceptions of sexual function questionnaires such as female sexual function index (fsfi) and pelvic organ prolapse/urinary incontinence sexual questionnaire-iuga revised (pisq-ir) in wsw.

there is a paucity of data regarding care of women who have sex with women (wsw). while some cohort studies are being performed in general gynecology, no studies document the reasons as to why wsw seek urogynecological care, or how pelvic floor disorders (pfds) affect sexual function in this population. another detrimental gap in current knowledge and a barrier to care for wsw is the lack of understanding of what would drive wsw to seek care, if there are special considerations for care, or if the commonly used condition specific questionnaires adequately reflect their concerns. the investigators aim to perform qualitative interviews to understand how pfds affect sexual function, and if commonly utilized sexual function questionnaires are inclusive to wsw.

Eligibility criteria:
inclusion criteria: * wsw who have a pfd (pelvic organ prolapse, urinary incontinence, fecal incontinence) * age \>18 * able to provide consent * able to read/write in english exclusion criteria: * wsw who have not been sexually active in the past 6 months * incarcerated patients * pregnant or lactating patients * unable to consent with study procedures or guided discussions * unable to speak english * no sexual activity in the past 6 months